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On the heels of our very popular conversation on quality culture with Marcia Baroni, The FDA Group’s Nick Capman recently sat down with Dr. Kimberly Garko, a life science executive with decades of experience in biologics, combination products, and medical devices, to approach the topic from a few different angles.
As a Chief Technical Officer, virologist, and microbiologist by training, Dr. Garko has built and led global quality teams in both startup and commercial environments. She challenges the default framing of quality as a cost center and offers an actual followable strategy for making quality a driver of value, trust, and sustainable growth.
This conversation is packed with action items you can start applying within your operation today.
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Dr. Garko’s key takeaways and recommendations
In case your time is short, here’s a focused distillation of the practical takeaways from the conversation.
Quantify and report the actual ROI of your quality initiatives. After implementing a quality initiative, like a new QMS module, targeted training program, or audit cycle, calculate and communicate what it actually achieved. This includes time saved (e.g. “200 hours annually”), cost equivalency (e.g. “$40,000 in FTE savings”), and risks averted (e.g. “prevented likely recurrence of X deviation”). Include this data in quarterly updates to leadership and directly tie it to avoided remediation costs or operational delays. “If you don’t report what you’ve saved, all leadership sees is money going in.”
Embed quality ownership across departments—not just QA! Set expectations that functional teams beyond QA own specific aspects of quality. For manufacturing, this could mean data-driven process control and deviation management. For supply chain, it means supplier qualification, quality agreements, and audits. For HR, tie onboarding and performance to quality culture and GxP awareness. Include quality-related KPIs in performance evaluations across functions. “It’s not just the 10 (or 30!) people in QA—it’s the whole organization.”
Invest in technical training for frontline staff. Go beyond basic SOP compliance by funding hands-on, role-specific training in areas like root cause analysis, process trending, and risk-based thinking. Deliver annual regulatory refreshers and host “lunch and learn” sessions to keep teams updated on new guidances and expectations. “Training and development are one of the best investments for good quality.”
Run regular self-inspections using external auditors. At least once a year, bring in experienced third-party auditors to inspect focused areas like complaint handling, batch record review, or supplier oversight. This yields unbiased findings, pressure-tests systems and teams, and reinforces a proactive posture to regulators. “Outside eyes help you see what you’re too close to.” (Talk to us if you’re due for an audit.)
Build a quality scorecard that evolves with your business. Don’t let metrics go stale! Reevaluate your KPI scorecard every 6–12 months or so. Measure both timeliness (e.g. CAPA closure rate) and effectiveness (e.g. recurrence rate). Include metrics for complaint trends, investigation aging, and supplier performance—and replace or adjust KPIs based on product lifecycle or organizational growth. “Ask: is this metric telling me anything useful today?”
Publish quality performance to leadership every quarter. Conduct quarterly Quality Management Reviews (QMRs) that include scorecard summaries, trend analysis, root cause context for misses, and clearly defined action plans with named owners and deadlines. Involve manufacturing, supply chain, and IT—not just QA—to encourage full business alignment. “It’s not about making it look better—it’s about explaining the why and what you’re doing.”
Create a “no bad news” policy to promote psychological safety. Reinforce across the organization that raising quality concerns is encouraged—and expected. Celebrate early risk identification, incorporate escalation expectations into the onboarding process, and model constructive, supportive leadership responses when issues arise. “The CEO never asked how much it would cost. He just said, ‘What do we need to do?’”
Assign a team member to monitor and brief on regulatory changes. Don’t wait for inspections or enforcement to drive action. Designate a staff member (or team) to actively track FDA and global guidances. Hold quarterly “regulatory intelligence reviews” to assess impact, and update SOPs and training before changes become mandated. “I've seen companies miss something and have to go back and fix it with twice the effort.”
Resist over-building homegrown tech; let validated tools lead your stack. When adopting enterprise systems or AI solutions, prioritize vendors with proven, configurable tools already used in regulated industries. Avoid custom systems unless you have the resources to support and scale them. Focus on ease of integration and data accessibility, not flashy dashboards. ”You can have every enterprise system, but if your people can’t get data out of it, it’s not working.”
Treat inspections as leadership development moments. Use internal and external audits not just as compliance checks, but as learning and development opportunities for staff and executives. Use them to assess inspection readiness, identify gaps in documentation or process clarity, and reinforce a culture of continual improvement. “I find inspections to be fun. They’re a learning opportunity.”
Ground every quality decision in patient impact. Keep the human consequences of your decisions front and center. Frame investments around protecting patient safety (e.g. immunocompromised populations), emphasize how shortcuts or missed signals can cascade downstream, and share personal stories that humanize your team’s mission. “As a mom of a type 1 diabetic, I always say: I hope they have a Kim over there.”
Kimberly Garko is a senior biopharmaceutical executive with over 25 years of experience leading global Quality, Manufacturing, and Technical Operations teams across biologics, combination products, and medical devices. She currently serves as SVP and Chief Technical Officer at Akebia Therapeutics, where she oversees the company’s end-to-end quality and manufacturing strategy from clinical development through commercialization.
A microbiologist and virologist by training, Dr. Garko brings deep technical and regulatory expertise spanning QMS, supply chain oversight, audit readiness, and lifecycle product management. She has successfully remediated FDA warning letters, led international inspection preparedness efforts, and implemented enterprise-wide compliance transformations in both startup and commercial organizations.
Before joining Akebia, she held senior leadership roles at Stryker, Pfizer, Dohmen Life Science Services, and multiple consultancies, where she advised clients on GxP compliance, CAPA execution, and organizational maturity. Dr. Garko holds a PhD in Virology from Louisiana State University Medical Center and multiple certifications in quality systems, lean manufacturing, and auditing.
Connect with her on LinkedIn here.
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